Valproic Acid (Fpia) Calibrator Kit
FDA 510(k) K895570 · Tudor Laboratories, Inc.
510(k) numberK895570
Submission
- Device name
- Valproic Acid (Fpia) Calibrator Kit
- Applicant
- Tudor Laboratories, Inc.
Dallas, TX, US - Received
- September 6, 1989
- Decision date
- September 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DLJ – Calibrators, Drug Specific
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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| K052015 | Dimension Extended Range Cyclosporine Calibrator, Catalog # DC108DLJ · Traditional | Dade Behring, Inc. | 09/12/2005SE |
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More from Labone, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K921904 | Thyroxine (Fpia) KitKLI · Traditional | 06/24/1992SE |
| K921903 | Thyroxine Calibrator KitJIS · Traditional | 05/26/1992SE |
| K913240 | Digitoxin (Fpia) KitLFM · Traditional | 09/06/1991SE |
| K895572 | N-Acetylprocainamide (Napa) Calibrator KitDLJ · Traditional | 10/30/1989SE |
| K895571 | N-Acetylprocainamide (Napa) (Fpia) KitLAN · Traditional | 10/25/1989SE |
| K895567 | Primidone (Fpia) KitLFT · Traditional | 10/20/1989SE |
| K895569 | Valproic Acid (Fpia) KitLEG · Traditional | 10/03/1989SE |
| K895568 | Primidone (Fpia) Calibrator KitDLJ · Traditional | 09/28/1989SE |
Questions and answers
When was Valproic Acid (Fpia) Calibrator Kit cleared by the FDA?
Valproic Acid (Fpia) Calibrator Kit (K895570) received a 510(k) decision of Substantially Equivalent on September 28, 1989, 22 days after the submission was received.
What is the product code of K895570?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.